FDA Corrective and Preventive Actions (CAPA) Procedure Guidelines

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About Corrective and Preventive Actions (CAPA)

The concept of Corrective and Preventive Actions (CAPA) was first proposed by the FDA in 2006 and was included as part of the quality system guidelines. CAPA is a systematic risk management approach aimed at collecting and analyzing information, identifying and investigating quality issues, and taking appropriate corrective and preventative measures. The CAPA procedure not only involves identifying problems but also includes verifying and confirming the measures taken to ensure that the information is promptly conveyed to relevant personnel.

Uses of CAPA

The CAPA procedure mainly analyzes, investigates, and assesses the impact of quality deviations that have already occurred, and takes measures to prevent similar problems from happening again. In the worst-case scenario, it may be necessary to immediately stop the production and distribution of all affected products. The deviations that trigger CAPA may come from multiple aspects of the quality management system, such as internal audits, customer feedback, or safety incidents caused by insufficient control measures.

Typical CAPA Procedure Flow

In most cases, the execution of CAPA is similar to the typical PDCA (Plan-Do-Check-Act) cycle:

Describe the problem in detail

Similar to the planning stage in the PDCA cycle, all CAPAs should start by describing the problem to ensure that all contents are accurately recorded.

Analyze the root cause

Once the problem is clearly defined, thoroughly analyze the root cause.

Implement, verify, confirm, and document necessary corrective and preventive measures

This step aims to address the root cause of the problem and ensure it does not occur again. Specifically, this may involve changes in the production process, training improvements, or other transformative measures.

Check the effects and evaluate the results

Similar to the action stage in the PDCA cycle, this process mainly verifies the effectiveness and success of the implemented measures. If the CAPA process is not successful or only partially successful, another CAPA process must be initiated.

Expectations of the FDA for the CAPA

Given that many of the FDA's inspections have pointed out the existence of inadequate CAPA procedures, it is crucial to re-examine the expectations of regulatory agencies regarding the CAPA process. The FDA released inspection guidelines, which clearly outline the specific objectives of investigators when evaluating CAPA systems and related documents.

With Proregulations' rich industry compliance experience, we have summarized the following key points, which can serve as the final checklist for evaluating whether the CAPA process complies with FDA regulations.

1. Verify CAPA system procedures

2. Identify the appropriate sources of product and quality issues

3. Identify the sources of product and quality information that may indicate adverse trends

4. Verify whether the CAPA system receives accurate, complete, and timely data

5. Use appropriate statistical methods

6. Determine whether the failure investigation procedures are followed

7. Take appropriate action

8. Confirm the effectiveness of corrective and preventative measures

9. Record and implement corrective and preventative measures

10. Ensure the appropriate dissemination of information

How to Determine When to Initiate CAPA?

Many companies may face overuse or underuse of the CAPA program, both of which pose risks. Although there are no clear rules to determine when to initiate CAPA, the following suggestions can help enterprises find a balance:

(1) Prioritize handling systematic or potential systematic problems

(2) Based on the following four questions, if the answer is "yes", then a formal CAPA should be conducted.

Has this incident or accident caused any injuries?
Has this problem occurred multiple times?
Can this problem be effectively managed by other means?
After risk assessment, is this problem considered a critical issue?

(3) Use trend analysis techniques

Our Services

Our company offers one-stop compliance services, enabling our clients to address product and quality issues through an effective CAPA process, thereby preventing or minimizing equipment failures.

Regulatory consultation and interpretation
Regulatory training
Gap analysis
Product compliance assessment
CAPA program review
Application material preparation and submission
Risk management

Proregulations is committed to assisting clients in promptly adjusting and optimizing their product launch strategies in accordance with the latest FDA regulations and guidance documents. If you are interested in our services, please contact us.